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Nov 7, 2024

FDA clears investigational new drug application for wet AMD gene therapy

The FDA granted investigational drug clearance to HG202, a CRISPR/Cas13Y RNA-editing therapy for neovascular age-related macular degeneration, according to a press release from HuidaGene.

According to the release, HG202 is the first CRISPR/Cas13Y RNA-targeting therapy in clinical development as well as the only clinical-stage CRISPR RNA-editing therapy for AMD.

After promising results from preclinical studies, HuidaGene is initiating a phase 1 dose-finding trial for the therapy.

“This open IND for HG202 by the U.S. FDA — the first regulator to have cleared CRISPR/Cas13 for clinical development — represents an important milestone for HuidaGene and the entire CRISPR gene-editing field of RNA editing,”

Read more: https://www.healio.com/news/ophthalmology/20241105/fda-clears-investigational-new-drug-application-for-wet-amd-gene-therapy?utm_source=selligent&utm_medium=email&utm_campaign=news

Source: Healio

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